INSTRUMENT MANAGER SOFTWARE
Received Nov 25, 2025 · Event occurred Oct 29, 2025
Report 1225673-2025-00007 · MDR key 23648790
Device
Generic name
Calculator/data Processing Module, For Clinical Use
Manufacturer
Data Innovations LlcProduct problems
- Computer Software Problem
- Computer Software Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
A USER FACILITY REPORTED TO DATA INNOVATIONS THAT A TEST RESULT COMMENT WAS BEING FILED INCORRECTLY AND REQUESTED ASSISTANCE FROM THE MANUFACTURER. HOWEVER, THE USER FACILITY DID NOT PROVIDE ADDITIONAL INFORMATION REGARDING THE COMMENT, THE TEST INVOLVED, HOW THE COMMENT WAS INCORRECTLY FILED, OR HOW IT SHOULD HAVE BEEN FILED. DESPITE MULTIPLE ATTEMPTS TO OBTAIN FURTHER DETAILS, DATA INNOVATIONS HAS BEEN UNABLE TO TROUBLESHOOT OR ASSIST IN RESOLVING THE COMPLAINT. THIS REPORT IS BEING SUBMITTED BECAUSE AS THE MANUFACTURER, DATA INNOVATIONS IS UNABLE TO RULE OUT MALFUNCTION OR PATIENT HARM.
Description of Event or Problem
A USER FACILITY REPORTED TO DATA INNOVATIONS ON 29 OCT 2025 THAT A TEST RESULT COMMENT WAS FILING INCORRECTLY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: DATA INNOVATIONS IS PROVIDING AN UPDATE TO CORRECT THE PREVIOUSLY ENTERED PRODUCT CODE. THE ORIGINALLY SUBMITTED CODE, JQO, HAS BEEN CORRECTED TO JQP. INFORMATION FROM ORIGINAL REPORT: A USER FACILITY REPORTED TO DATA INNOVATIONS THAT A TEST RESULT COMMENT WAS BEING FILED INCORRECTLY AND REQUESTED ASSISTANCE FROM THE MANUFACTURER. HOWEVER, THE USER FACILITY DID NOT PROVIDE ADDITIONAL INFORMATION REGARDING THE COMMENT, THE TEST INVOLVED, HOW THE COMMENT WAS INCORRECTLY FILED, OR HOW IT SHOULD HAVE BEEN FILED. DESPITE MULTIPLE ATTEMPTS TO OBTAIN FURTHER DETAILS, DATA INNOVATIONS HAS BEEN UNABLE TO TROUBLESHOOT OR ASSIST IN RESOLVING THE COMPLAINT. THIS REPORT IS BEING SUBMITTED BECAUSE AS THE MANUFACTURER, DATA INNOVATIONS IS UNABLE TO RULE OUT MALFUNCTION OR PATIENT HARM.